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Allergy & Immunology

Allergy Therapeutics reports positive phase 2 U.S. FDA meeting on Pollinex Quattro Ragweed

Published in Medical Letter on the CDC and FDA, March 4th, 2007

Allergy Therapeutics plc (AGY), a specialist pharmaceutical company focused on allergy vaccination, announced that it has concluded a successful end of phase 2 meeting with the U.S. Food and Drug Administration (FDA) for its ultra short course allergy vaccine Pollinex Quattro Ragweed.

Following a broad ranging review of Pollinex Quattro's preclinical, manufacturing and clinical data, and subject to minor clarifications, the FDA has accepted the company's plans to conduct a single pivotal phase 3 trial for registration.

With a clear understanding of the path to achieve the regulatory submission, the company is finalizing preparations for a randomized,...

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